Associate Director, Drug Substance & Manufacturing (Late-Stage)

Responsibilities

• Your day-to-day:
• Support lifecycle management of Phase‑appropriate to commercial DS processes, ensuring robustness and scalability.
• Support manufacturing, sourcing, and control of starting materials and key intermediates.
• Ensure alignment between starting material controls, impurity strategy, and DS control strategy.
• Design and support DoE and process characterization studies to establish CPPs, NORs, and control strategies.
• Translate process understanding into defensible control strategies for NDA/MAA submissions and inspections.
• Support comparability assessments for process, scale, or site changes.
• Support establishment and execution of CPV programs for DS manufacturing.
• Support impurity fate and purge, GTI/nitrosamine risk assessments, and specification justification.
• Maintain control of solid‑state form and physical attributes to ensure DP and commercial alignment.
• Support late‑stage CMC regulatory content (IND updates, NDA/MAA Module 3 -2.S).
• Serve as day‑to‑day technical interface with DS and starting‑material CDMOs, including review of batch records, deviations, and change controls.

Requirements

• S. or Ph.D. in Process Chemistry, Organic Chemistry, or Chemical Engineering.
• 8+ years (Ph.D.) or 10+ years (M.S.) experience in small molecule DS development, with late stage or registration exposure.
• Experience with RSM strategy, DoE/process characterization, and CPV.
• Familiarity with ICH Q7-Q12, Q3A/C/D, and M7.
• Experience working with outsourced CDMOs.
• Experience contributing to NDA/MAA filings preferred.
• What makes Rapport special:
• Every role has meaning. We're determined to discover a better way for patients, and you'll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas - we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you'll enjoy spending time with.
• Leadership that CARES - about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston - we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.
• Your Compensation:

Benefits

Additional Information

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we're driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we're doing this with extraordinary science and awesome people (affectionately called Rapptors). Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder. The strength of Rapport comes from our Rapptors - who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you're as excited about this opportunity as we are! This role is based in Boston, MA with onsite presence required Monday-Wednesday

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at rapporttherapeutics? Share your experience